| 1. |
- Jonas, Elisabeth, et al.
(författare)
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The science behind GM research animals
- 2024
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Ingår i: Biotech Animals in Research : Ethical and Regulatory Aspects. - 9781138369214 ; , s. 9-22
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Bokkapitel (refereegranskat)abstract
- Animals have been widely used in research to test new methods, procedures or treatments. Methods applied in animal research range widely and include the application of genetic modifications. These methods have been developed since the 1980s and have been widely applied in research animals not only to verify and develop the methodologies but also to test very specific applications of it. Genome editing has increased the interest of genetic modifications even more, as it promises a simpler and faster way to modify the genome. It is applied to a wide range of animal species including farm animals. Genome editing makes use of nucleases and does not need an external gene construct as it has been the case in classical genetic modifications. It instead is based on the self-repair mechanisms of the DNA in the cell, leading to site-directed mutagenesis. While the transformation of the genetic change into the genome is more simple, precise and successful, also genome editing requires the use of advanced reproductive techniques. The success rate of the entire procedure, meaning the survival of the modified animal, however, is still medium to low, depending on the species. Much effort is therefore especially put into the improvement of the success rates of the reproductive techniques, which are required during the modification. There are a number of options of how the methods of genetic modifications are used in the future, including in silico methods. The parallel application of such alternatives as well as improvements of the methods with higher success rates might lead to a significant reduction of animals used in research of genetic modifications.
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| 2. |
- Röcklinsberg, Helena
(författare)
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An overview of the regulation of genetically altered animals in research
- 2024
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Ingår i: Biotech Animals in Research : Ethical and Regulatory Aspects. - 9781138369214 ; , s. 23-72
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Bokkapitel (refereegranskat)abstract
- This chapter presents existing legal and regulatory structures and some of the overarching governance practices that apply to “genetically modified” animals in what are considered “research” settings in selected countries or geopolitical units around the world. It incorporates the ethics of animal use by reference and concentrates on the statutory regulation and softer governance systems in situations in which animals that are clones (or their offspring) or that have intentional genomic alterations that fit within the rubric of “techniques of modern biotechnology” as defined by the WHO and FAO are used for research purposes. The chapter defines ‘What is an animal?’, the meaning of “modified” or “altered” and of “research”, then delves into the nuances around terms such as “regulation” and “governance”. It looks at the special case of non-human primates before providing a detailed compendium of the laws, regulations, and standards pertaining to research involving genetically modified animals in all major regions of the world.
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| 3. |
- Röcklinsberg, Helena
(författare)
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Beyond welfare
- 2024
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Ingår i: Biotech Animals in Research : Ethical and Regulatory Aspects. - 9781138369214 ; , s. 99-118
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Bokkapitel (refereegranskat)abstract
- This chapter introduces the notion of ethical deliberation as it differs from scientific inquiry. It then moves on to describe some of the pertinent ethical issues within animal ethics. First the question is of whether (some) animals can be said to be of ethical importance or whether only humans have this status followed by the question of whether only welfare concerns are ethically relevant or whether there are ethical considerations that go beyond welfare. As examples the issues of the death of animals and the integrity of animals are discussed.
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| 4. |
- Röcklinsberg, Helena
(författare)
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The ethical assessment process
- 2024
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Ingår i: Biotech Animals in Research : Ethical and Regulatory Aspects. - 9781138369214 ; , s. 173-190
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Bokkapitel (refereegranskat)abstract
- Animal-based research not only evokes ethical questions on a theoretical level, as discussed in the previous chapters, but also calls for an ethical assessment within a legal framework. In this chapter the main elements of the ethical review systems in North America and Europe are described and discussed. The focus lies on the core task of these Animal Ethics Committees, i.e., ensuring the principle of 3Rs are applied in the suggested research protocols and the performance of a Harm-Benefit Analysis, including, e.g., welfare assessment and research quality, while elaborating on current literature in the field and issues arising due to use of genetically modified animals. Further, challenges in the review system in terms of defining the role of committee members, and ensuring transparency and societal trust are highlighted.
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| 5. |
- Röcklinsberg, Helena
(författare)
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Welfare and 3Rs
- 2024
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Ingår i: Biotech Animals in Research : Ethical and Regulatory Aspects. - 9781138369214 ; , s. 73-98
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Bokkapitel (refereegranskat)abstract
- Although animal welfare is practised as a modern interdisciplinary science, it originates in philosophical theories of ‘the good life’ and values from social movements. We provide a brief introduction to the predominant theories of animal welfare and relate these to the challenges of assessing the welfare of GM/GE animals that might have altered biological functions and behaviours. Many applied frameworks for animal welfare are hybrid views, which contain elements of the different theories. We outline some of these frameworks with particular emphasis on the 3Rs, Replacement, Reduction, and Refinement, due to its wide application in the scientific community. We address the emerging questions and dilemmas in the wake of the new editing tools and their potential impact on the welfare of laboratory animals, i.e., the ‘pros’ and ‘cons’ of tailoring animals to fit the experiments to which they will be subjected. Finally, we present three actual cases and relate these to the different approaches to animal welfare.
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